Quick Facts at a Glance
- Recall Date
- October 29, 2025
- Hazard Level
- HIGH
- Brand
- BBraun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BBraun Medical
- Product type
- IV Administration Set
- Model numbers
- 490469, 490470
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 29, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
IV admin sets deliver medications or fluids during medical procedures. This recall concerns piggyback setups in gravity or pump-assisted lines.
Why This Is Dangerous
Backflow can lead to misdose or contamination and line occlusion can interrupt infusion, potentially impacting patient safety.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate action required in clinical settings. Utilities and refunds may take weeks; patient safety depends on stopping use and replacing with approved sets.
Practical Guidance
How to identify if yours is affected
- Inspect catalog numbers on packaging: 490469 and 490470.
- Confirm compatibility with Infusomat Space, Outlook, and Vista Basic pumps.
Where to find product info
UDI labels on packaging and device labeling; recall notice on FDA enforcement page.
What timeline to expect
Refunds or replacements are issued per manufacturer directions; typical processing spans several weeks.
If the manufacturer is unresponsive
- File a complaint with the FDA if the company is slow to respond.
- Document all attempts to contact the manufacturer.
How to prevent similar issues
- Verify catalog numbers and UDIs before use.
- Use only approved IV sets that match your pump model.
- Stay updated with FDA recall notices for new guidance.
Documentation advice
Keep packaging labels, UDIs, recall notices, and correspondence with BBraun Medical.
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Product Details
Catalog Numbers: 490469 and 490470. Description: IV Admin Set with 15 drops/mL, 132 in; 60D 2 CARESITE VLV, 132 in. Primary UDI-DI: 04046964958816; Unit of Dose UDI-DI: 04046964958809. Secondary Catalog Number: 490470; Primary UDI-DI: 04046964958830; Unit of Dose UDI-DI: 04046964958823. Sold worldwide including US, Canada, Germany, Guatemala, Singapore.
Reported Incidents
No specific incident counts are provided in the recall notice. The FDA enforcement page lists the hazard and quantity but does not enumerate injuries or incidents.
Key Facts
- 104,784 units recalled worldwide
- Catalog Numbers 490469 and 490470
- Recall status: ACTIVE as of 2025-12-03
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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